Study of a Pandemic Influenza Vaccine in Children

Phase II Study of a Pandemic Influenza Vaccine in Children

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370864

Enrollment

220

Registered

2006-09-01

Start date

2006-09-30

Completion date

2007-07-31

Last updated

2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza

Brief summary

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.

Interventions

BIOLOGICALH5N1 pandemic influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Months to 8 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy children aged greater or equal to 6 months to less than 9 years * Normal gestation period

Exclusion criteria

* History of clinically significant medical conditions * History of Guillain Barre syndrome or active neurological disease

Design outcomes

Primary

Measure	Time frame
Safety and immunogenicity	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026